In a randomized, double‑blind, placebo‑controlled phase 3 trial of 90 patients with severe PTSD (including common comorbidities), MDMA‑assisted therapy produced a large, significant reduction in PTSD symptoms versus placebo (mean CAPS‑5 change −24.4 vs −13.9; P<0.0001, d=0.91) and improved functioning (SDS: P=0.0116, d=0.43). Treatment was well tolerated with no signals of abuse potential, increased suicidality or QT prolongation, indicating MDMA‑assisted therapy is a promising intervention warranting expedited evaluation.
- Published
- Journal
- Nature Medicine
- Authors
- Mitchell, J., Bogenschutz, M. P., Lilienstein, A., Harrison, C., Kleiman, S., Parker-Guilbert, K., Ot’alora G, M., Garas, W., Paleos, C., Gorman, I., Nicholas, C. R., Mithoefer, A. T., Mithoefer, M. C., Carlin, S. C., Poulter, B., Quevedo, S., Wells, G., Klaire, S. S., van der Kolk, B., Tzarfaty, K., Amiaz, R., Worthy, R., Shannon, S., Woolley, J. D., Marta, C. J., Gelfand, Y., Hapke, E., Amar, S., Wallach, Y., Brown, R., Hamilton, S., Wang, J. B., Coker, A., Matthews, R., de Boer, A., Yazar-Klosinski, B., Emerson, A., Doblin, R.